Here is a patient guide to stem cells with the key factual things you need to know.
For better or worse, I am in the unique position of being a stem cell scientist and also a patient since I had cancer 2 years ago. Looking on the bright side this gives me a unique perspective on things.
I know there are thousands of people out there looking for more practical information about stem cell therapies and treatments. These folks understandably are using the Internet to look for some clear, good info on stem cell treatments either for themselves or their loved ones. Too often the info that is out there is either wrong, misleading, or overly complex.
So in this post I want to address this need speaking as a scientist, patient advocate and cancer survivor in the form of 10 key facts to help you guide your way through the jungle of stuff out there about stem cells. Note, I have no conflict of interest on stem cell treatments since I do not offer them and am not involved directly in any clinical study as a researcher. Therefore I have no reason to mislead you.
1) Stem cells are drugs and possibly permanent ones. Yeah, they are extremely unusual drugs, but they are drugs. The FDA considers them drugs. Unlike other drugs, once a patient receives a stem cell drug, it will not necessarily simply go away like other drugs because a stem cell drug consists of living cells that often behave in unpredictable ways. What this means is if the stem cells are doing bad things your doctor has no way to stop it.
2) Like any drug, even aspirin, stem cells treatments will have side effects. Not maybe. Definitely. Our hope is the side effects will be relatively mild.
3) The only stem cell treatment explicitly approved by the FDA for use in the U.S. is bone marrow transplantation. What this means is that any other stem cell treatment you see advertised on Facebook or Google or elsewhere that indicates it will be given to you inside the U.S. may in fact be illegal and unsafe. The exception to this is if it is part of an FDA-approved clinical trial.
4) If you venture outside the U.S. for a stem cell treatment, use extra caution and have a knowledgeable physician inside the U.S. guiding you. We have to avoid the trap of thinking that only the U.S. can offer advanced medical treatments, but on the other hand within the U.S. you have the added safety of the FDA, which is trying to protect you. In the vast majority of other countries regulatory agencies are practically non-existent or are far less strict than the FDA.
5) Stem cells are not a cure all. I am as excited as anybody about the potential of stem cells to treat a whole bunch of diseases and injuries, but they are not some kind of miracle cure for everything. When a doctor offers to inject some kind of stem cells or a stem cell-derived product into a patient either into the bloodstream or into a specific place that is injured such as a shoulder, we just do not know at this point if it will do any good with the exception of bone marrow transplant.
6) Don’t let celebrities be your guide to medical care. The number of famous people getting stem cell treatments is increasing including sports stars and politicians. Don’t let what these folks do influence what you decide to do about your health. Just because they are famous do not believe for one minute that they are any more informed than you or your personal doctor about medical treatments or stem cells. If anything I think sometimes famous people are more reckless with their health than average people like you and me.
7) Reach out to scientists as a source of info. As a scientist I am always happy to hear from people outside the scientific community with questions about stem cells and other research. I can’t speak for all stem cell scientists but you might be surprised at how likely it is that if you send them a very short, clear email with one or two questions that they will respond and be helpful. We can’t or shouldn’t offer medical advice, but we can give our perspectives on stem cell research and its clinical potential, etc. Just do not cold call scientists as you are unlikely to find them that way and even if you do, they may be cranky. Email.
8 ) The people selling you non-FDA approved stem cell treatments want your money. Unlike stem cell researchers, the people out there advertising stem cell treatments that are not FDA approved are only really after one thing: your money. As such they will do their best to convince you that their treatment is safe and effective. They may offer patient testimonials either from patients who truly believe they were helped or from people who are paid to say the treatment helped them. The bottom line is that the sellers of dubious stem cell treatments simply want your money.
9) There is no such thing as completely “proven safe” and if something sounds too good to be true, it probably is. I am contacted fairly regularly by patients or their families and they often mention that the doctors offering stem cell treatments told them that the treatments are proven safe…or that umbilical cord blood cannot harm you….or that your own stem cells cannot harm you..or that adult stem cells are harmless. I’ll believe it when the FDA says it is so and you should be skeptical too.
10) The most important thing is data and you have a right to see it before treatment. Before you or a loved one get a stem cell treatment, ask two key questions. First, is the treatment FDA approved and if not, why not? Second, can you please show me the data (preferably published and, no, on the web doesn’t count as published) that proves your treatment is safe and effective. See what kind of answer you get. If they criticize the FDA then that is a warning flag. If they refuse to show you data, then that is a big red warning flag. They may say it is confidential or that it is not published yet, but as a patient you have a right to see the data, assuming they have any data at all.
These facts will hopefully change over the coming years, but right now I think they represent reality. I know as patients we need hope and stem cells offer that in many ways, but unapproved stem cell treatments will at best take your money for nothing, and at worst will endanger you or your loved ones.
The field is moving forward…
McEwen Centre Research Breakthroughs 2012
http://youtu.be/uKpYyvDSsRk
2009 Death in Ecuador – UK Family now comes forward
Article here:
http://www.croydonguardian.co.uk/news/9531837.Family_wants_foundation_in_memory_of_paraplegic/
Leading to this find and mothers comment below – this is Horrific!
http://www.apparelyzed.com/forums/topic/22217-paraplegic-man-died-following-stem-cell-operation-in-ecuador/
Ricky was scammed and no mother should see her son being resussitated for 45 mins to be told he was dead and then an hour later tell me he was alive again. He lived for a further two days. it took them one hour to get him into intensive care as they didnt know what to do with him. he was taken away in a camper van critically ill for a brain scan and then brought back. when he passed away they took him away on the back of a pick up truck and embalmed him within 2 hours of his death. I was not allowed to see him in the mortuary as the British Embassy said it would be too upsetting as he wasnt kept in very good condition there. The doctor met me at the airport and showed me pictures on his laptop of pigs being paralysed and then again with them having stem cells and dragging their back ends along the floor. it was horrific and i did not want to see that after my son had passed away. He told me I could ruin his work so basically if i kept quiet I would not have to pay the additional 10200 dollars for the icu treatment after the operation. I told the doctor he should learn lessons from my sons death. approx a year later I emailed the doctor pretending to be a potential patient. I specifically asked were there any risks, deaths or icu admissions from the treatment. His answer was no to all questions. He had conveniently forgotton my son. He had not learned the lesson
Caution:
Cathy O’Neil: How Big Pharma Cooks Data –The Case of Vioxx and Heart Disease
Disclosure
Madigan has been a paid consultant to work on litigation against Merck. He doesn’t consider Merck to be an evil company by any means, and says it does lots of good by producing medicines for people. According to him, the following Vioxx story is “a line of work where they went astray”.
Yet Madigan’s own data strongly suggests that Merck was well aware of the fatalities resulting from Vioxx, a blockbuster drug that earned them $2.4b in 2003, the year before it “voluntarily” pulled it from the market in September 2004. What you will read below shows that the company set up standard data protection and analysis plans which they later either revoked or didn’t follow through with, they gave the FDA misleading statistics to trick them into thinking the drug was safe, and set up a biased filter on an Alzheimer’s patient study to make the results look better. They hoodwinked the FDA and the New England Journal of Medicine and took advantage of the public trust which ultimately caused the deaths of thousands of people.
The data for this talk came from published papers, internal Merck documents that he saw through the litigation process, FDA documents, and SAS files with primary data coming from Merck’s clinical trials. So not all of the numbers I will state below can be corroborated, unfortunately, due to the fact that this data is not all publicly available. This is particularly outrageous considering the repercussions that this data represents to the public.
Merck nevertheless launched an ad campaign with Dorothy Hamill and spent $160m (compare that with Budweiser which spent $146m or Pepsi which spent $125m in the same time period).
http://www.nakedcapitalism.com/2012/02/25244.html
How much did gern need to carry out their clinical trials?…the cost of an ad budget for a drug….sigh.
Super list
I will use this with our school workshop